Dautel 2019.

Trial name or title	Multifactorial intervention for hip and pelvic fracture patients with mild to moderate cognitive impairment: study protocol of a dual‐centre randomised controlled trial (OF‐CARE)
Methods	A randomised controlled trial to compare a multifactorial transitional care intervention after inpatient rehabilitation with usual care for people who have sustained a hip or pelvic fracture and who have mild to moderate cognitive impairment.
Participants	Number: Will recruit 240 hip or pelvic fracture patients admitted to the geriatric rehabilitation departments of the Robert‐Bosch‐Hospital Stuttgart and the Agaplesion Bethanien Hospital Heidelberg (both in Germany) who have mild to moderate cognitive impairment. Eligibility criteria (patient participant): Patient inclusion criteria: Hip or pelvic fracture within the last 3 months Mild to moderate cognitive impairment (MMSE score of 17 to 26) Age ≥ 65 years Minimum visual acuity (corrected vision, Snellen fraction > 20/400) Living in home environment or assisted living Able to walk 4 metres with or without walking aid Patient exclusion criteria: Delirium, identified by the Confusion Assessment Method Severe somatic or mental illness Terminal disease Moderate to severe aphasia (except amnestic aphasia) or severe apraxia Insufficient hearing ability for receiving calls or no telephone accessibility Insufficient knowledge of German language Place of residence outside the Stuttgart and Heidelberg area Eligibility criteria (caregiver participant): Family members who provided care for the fracture patients and met the following inclusion criteria were also invited to participate in the study. Caregiver inclusion criteria: Supports patient ≥ 10.5 hours per week (informal care in ADLs, instrumental ADLs and supervision) The support is not commercial Age ≥ 18 years Willing to attend a personal consultation at the patient participant's home Caregiver exclusion criteria: Current mental illness or cognitive impairment that affects the ability to understand the requirements of the assessments, to participate in the intervention, or to give informed consent No telephone available Insufficient hearing ability to conduct phone calls Not able to understand and speak German Group allocation: Patient participants were randomly assigned to the experimental or control group in a 1:1 ratio after the first assessment and before discharge from inpatient rehabilitation. Computer‐generated random allocation was done by an independent randomisation centre, and sealed envelopes were used. Diagnosis/cognitive status: Patient participants with an MMSE score of 17 to 26 points. Age: Patient participants aged 65 years and over Gender mix: Not specified Usual place of residence: Not specified Surgical management: Not specified Comorbidities: Not specified
Interventions	Intervention arm: Usual care plus a multifactorial OF‐CARE intervention that centres on: physical activity promotion; an individually tailored, progressive exercise home programme; and care counselling for the participants and their participating caregivers (if existing). Home visit provided 2 to 6 weeks postdischarge (maximum 2 hours duration) developed by an exercise instructor (physiotherapist or sports scientist) and a lay instructor. The aim of this visit is: (a) to set at least 1 physical activity goal; (b) to specify a tailored exercise programme on strength, balance, and gait; and (c) to introduce and instruct a lay instructor. Activity goals are set using a card‐sorting exercise, providing a visual representation of activities to develop goals towards. Importance of physical activity and exercise were discussed with participants. Individually tailored training programme undertaken with balance and strength exercises, to meet the needs of participants. Lay instructors then visit twice‐weekly for 4 months (each visit maximum 2 hours) where the exercise programme is supervised. The exercise instructor supervises the lay instructor by a minimum of 5 telephone calls or email contacts and a further 2 home visits. During these, the exercise components are reviewed and adapted if needed and environmental assessment made. Exercise instructor also telephones each participant 5 times during the intervention period to feedback progress and address any issues raised. In addition, at least 1 of the following skills/interventions are delivered during each of the 3 home visits the exercise instructor performs: (1) addressing a minimum of 3 fall hazards and options for modification; (2) identifying situations in which the participant feels insecure when walking or experiences fear of falling and discussing coping strategies; (3) using walking aids safely; (4) possible self‐help strategies after a fall has occurred; (5) discussing or practising backward chaining as a strategy to get up independently from the floor; and (6) further physical activity promotion (e.g. resuming daily activities and routines, participation in community activities or local exercise classes). In addition, after the initial visit, a care counsellor is contacted. They are informed about the patient participant’s goals and unmet care needs. The care counsellor then intervenes during 1 initial home visit (maximum duration 2.5 hours) and up to 5 telephone calls throughout the intervention period. They work to facilitate the participant’s daily routines, pleasurable activities, participation, and adequate care needs. This is to the participant and (if existing) the principal caregiver. The caregiver receives a standardised problem‐solving intervention and information via a booklet on caregiver issues, falls prevention, memory aids for participants, skills to recognise and dealing with care recipient’s pain or depressive symptoms and recommended environmental adjustments, nutrition, and how to behave in the instance of a participant fall. Information is provided to caregivers on local supported and health promotion strategies. Control arm: Usual healthcare provision. All participants receive a face‐to‐face advice session (maximum duration 60 minutes) on recommended regular physical exercises and tips for fall prevention. These are summarised in an illustrated advice booklet.
Outcomes	Time points: (‐T1) end of inpatient rehabilitation, only participant; (T1) pre‐intervention at participant’s home: week 2 to 6 postdischarge; (T2) postintervention at participant’s home: 4 months after T1; (T3) follow‐up at participant’s home: 3 months after T2 Outcomes (patient participant): Daily walking duration (24 hours) using a thigh‐worn inertial senior for 3 consecutive weekdays (activPAL3, PAL Technologies Ltd, Glasgow, UK); Short Physical Performance Battery (SPPB); Fear of Falling Questionnaire‐revised (FFQ‐R); Short Falls Efficacy Scale‐International (Short FES‐I); falls number (diary); Quality Of Life in Alzheimer’s Disease questionnaire (QOL‐AD); Montgomery‐Asberg Depression Rating Scale (MADRS); Barthel Index (BI); daily activity profile measured with activPAL3 including average daily number of steps, number of walking bouts, daily upright duration, daily number of sit‐to‐stand transfers; functional performance using an accelerometer (DynaPort Hybrid, McRoberts, The Hague, the Netherlands) to assess: sway area and sway path; angular velocity and fastest sit‐to‐stand; Western Ontario and McMaster Universities Osteoarthritis‐Scale Pain subset; Nuremberg Age Inventory (NAI:ZN‐G); modified German Social Support Questionnaire (F‐SozU Part B); economic evaluation questionnaire (health costs, care costs, and intervention costs); adverse events. Outcomes (caregiver participant): Centre for Epidemiological Studies ‐ Depression Scale (CES‐D), Sense of Competence Questionnaire (SCQ); Carer‐related Quality of Life questionnaire (CarerQoL); Giessen Subjective Complaints List (GSCL); Social Problem‐Solving Inventory ‐ revised/subscale (SPSI‐R:S); Leisure Time Satisfaction Measure (LTS); Revised Memory and Behaviour Problems Checklist/subscale frequency (RMBPC); economic evaluation questionnaire (health costs, care costs, and intervention costs); Time Burden Questionnaire ‐ including 3 dimensions of care ((1) body care; nutrition, mobility, (2) household help (e.g. housekeeping), (3) additional supervision). Adherence to the intervention was recorded for both patient participant and caregiver participant intervention provision.
Starting date	27 July 2015
Contact information	Dr Klaus Pfeiffer, Robert Bosch Hospital, Clinic for Geriatric Rehabilitation, Auerbachstr. 110, Stuttgart, 70376, Germany. Email: Klaus.Pfeiffer@rbk.de
Notes	Proposed end date: January 2019 ISRCTN registration: ISRCTN69957256 Trial registration last updated: 2 May 2019 ‐ completed Recruitment process acknowledging cognitive impairment: Existing legal guardians or authorised representatives were involved in the information and consent process in any case, otherwise the closest family member if possible.